Spectranetics wins 510(k) clearance for laser atherectomy cath

Spectranetics (NSDQ:SPNC) said yesterday it won FDA 510(k) clearance for its next-generation Turbo-Power laser atherectomy catheter for treating in-stent restenosis. The Turbo-Power laser catheter treats at the tip and debulks lesions in a single step with remote automatic rotation for accurate directional control, the Colorado Springs, Colo.-based company said. “Patients with ISR present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease. Turbo-Power, with its eccentric tip design, allows far more effective debulking of ISR lesions and I am optimistic the tool will further improve outcomes for patients. The device is backed by Level 1 clinical data proving both safety and efficacy at six months. With proven evidence, Turbo-Power will clearly drive practice adoption and set a new standard of care in ISR treatment,” New Cardiovascular Horizons chair Dr. Craig Walker said in a press release. Results from the 318-patient Excite ISR trial examining patients being treated for femoropopliteal artery in-stent restinosis showed a 5.4% rate of major adverse events with the device compared to 20.8% compared to balloon angioplasty alone. The study also reported a 78.3% rate of freedom from target lesion revascularization through 6 months compared to 58.9% with PTA alone. “With a relentless focus on improving patient care, Spectranetics is pleased to bring Turbo-Power, the next-generation in-...
Source: Mass Device - Category: Medical Equipment Authors: Tags: 510(k) Catheters Regulatory/Compliance Vascular Spectranetics Corp. Source Type: news